Above-Label Doses for Treating Psoriasis Can Lead to Higher Annual Treatment Costs

Patients with psoriasis often have lower success treatments with biologic agents in clinical practice than clinical trials, leading to higher doses and therefore higher annual treatment costs.

A study recently published in the Journal of Managed Care & Specialty Pharmacy examined above-label use of adalimumab, etanercept, and ustekinumab in treating patients with psoriasis. A dose is considered above-label if it is at least 10% higher than what is indicated on the label, as defined in the study. This above-label use was considered extensive if it occurred for 180 days or more over a 12-month period.

The researchers performed a retrospective study, using data from a large US claims database to identify patients with psoriasis with at least 1 claim for either adalimumab, etanercept, or ustekinumab. The patient also had to have continuous pharmacy benefits for 12 months before and 18 months after the first use of the biologic at its recommended dose.

During the analysis of the patients, an association between the mean number of days of above-label use and additional costs of extensive above-label use was discovered.

“Cost models frequently rely on the labeled dose of medication to determine cost-effectiveness,” the authors wrote. “Patients, however, are often treated with doses outside the standard labeling. Such dosing can have a large effect on the cost of the treatment.”

Of the 3310 patients in the study, extensive above label use averaged 282 (±55) days for etanercept, 279 (±57) days for adalimumab, and 305 (±43) days for ustekinumab. This equated to additional costs per patient per day of $69 for etanercept, $68 for adalimumab, and $64 for ustekinumab and total additional annual costs for extensive above label care use of $5,623,362 for etanercept, $701,964 for adalimumab, and $1,304,790 for ustekinumab.

Prior to the introduction of biologics to treat psoriasis, patients relied or medications that had considerable toxicity, such as methotrexate and cyclosporine. With those drugs, the goal of treatment was not to attain clearance of psoriatic plaque, but to attain a “reasonable degree of disease control improvement,” the authors wrote.

“Biologics have also revolutionized the cost of psoriasis treatment,” they added. “The high cost of these agents adds to the pressure for all parties to be wise and responsible stewards of limited medical resources.”